Osartil Tablet

Hypertension: Osartil tablet is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents (eg. thiazide diuretics).

Renal Protection in Type-2 Diabetic Patients with Proteinuria: Osartil tablet is indicated to delay the progression of renal disease in hypertensive type-2 diabetics with proteinuria, defined as urinary albumin to creatinine ratio >300 mg/g.

Losartan Potassium is the first non-peptide orally active angiotensin II receptor blocker. It binds to the AT1 receptor found in many tissues (e.g. vascular smooth muscle, adrenal gland, kidneys and the heart) and reduces several important biological actions including vasoconstriction and the release of aldosterone responsible for hypertension.

The usual starting and maintenance dose is 50 mg once daily for most patients. If the antihypertensive effect using 50 mg once daily is inadequate, 25 mg twice daily is recommended prior to increasing the dose. For patients with intravascular volume-depletion (e.g., those treated with high-dose diuretics), a starting dose of 25 mg once daily should be considered. Losartan Potassium can be administered once or twice daily. The total daily dose ranges from 25 mg to 100 mg.

Patients upto 75 years: No initial dosage adjustment is necessary for this group of patients.

Patients over 75 years: Presently there is limited clinical experience in this group; a lower starting dose of 25 mg once daily is recommended.

Rifampicin and fluconazole reduce levels of active metabolite of Osartil. Concomitant use of Osartil and hydrochlorothiazide may lead to potentiation of the antihypertensive effects. Concomitant use of potassium-sparing diuretics (eg, spironolactone, triamterene, amiloride), potassium supplements or salt substitutes containing potassium may lead to increases in serum potassium. The antihypertensive effect of losartan may be attenuated by the non-steroidal anti-inflammatory drug indomethacin. The use of ACE-inhibitor, angiotensin receptor antagonist, an anti-inflammatory drug and a thiazide diuretic at the same time increases the risk of renal impairment.

Losartan Potassium is contraindicated in pregnant women and in patients who are hypersensitive to any component of this product. Losartan Potassium should not be administered with Aliskiren in patients with diabetes.

The side effects with the use of Osartil are mild and transient in nature. The most common side effects are dizziness, diarrhea, nasal congestion, cough, upper respiratory infection. Other side effects are fatigue, oedema, abdominal pain, chest pain, nausea, headache & pharyngitis.

Pregnancy Category D. The risk to the fetus increases if Losartan Potassium is administered during the second or third trimesters of pregnancy. It is not known whether Losartan Potassium is excreted in human milk, as many drugs are excreted in human milk and because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Use of Osartil during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. In patients who are intravascularly volume-depleted (e.g., those treated with high-dose diuretics), symptomatic hypotension may occur. Plasma concentration of Osartil is significantly increased in cirrhotic patients. Changes in renal function including renal failure have been reported in renal impaired patient.

Use in renal impairment: No initial dosage adjustment is necessary in patients with mild renal impairment (i.e. creatinine clearance 20-50 ml/min). For patients with moderate to severe renal impairment (i.e. creatinine clearance <20 ml/min) or patients on dialysis, a lower starting dose of 25 mg (one Araten-50 tablet) once daily is recommended. Use in patients with intravascular volume depletion: For the very small proportion of patients who have intravascular volume depletion (e.g. those treated with high-dose diuretics), a starting dose of 25 mg (one Araten-50 tablet) once daily is recommended.

Use in hepatic impairment: A lower dose should be considered for patients with a history of hepatic impairment. Araten may be administered with other antihypertensive agents. Araten may be administered with or without food.Contra-indications, warnings, etc. Contra-indications: Osartil is contra-indicated in pregnancy and in patients who are hypersensitive to losartan. Warnings: Based on pharmacokinetic data which demonstrate significantly increased plasma concentrations of losartan in cirrhotic patients, a lower dose should be considered for patients with a history of hepatic impairment. Other drugs that affect the renin-angiotensin-aldosterone system may increase blood urea and serum creatinine in patients with bilateral renal artery stenosis of the artery to a solitary kidney. Similar effects have been reported with losartan; these changes in renal function may be reversible upon discontinuation of therapy. Osartil should not be used with potassium-sparing diuretics.

Angiotensin-ll receptor blocker

keep in a dry place away from light and heat. Keep out of the reach of children.